Venaxis Begins Enrolling Patients in APPY1 Pivotal Study
Venaxis (NASDAQ: APPY) today announced that it has begun enrolling patients into its pivotal clinical study in the United States. Based on current enrollment expectations, the Company anticipates completing the study in six to eight months and filing with the FDA for regulatory clearance of APPY1 in the fourth quarter 2013.
Steve Lundy, President and CEO of Venaxis, stated, "With our pivotal study now underway, we anticipate 2013 will be a transformative year for Venaxis. The pivotal clinical study is being conducted at 28 leading hospital sites, each of which are enthusiastic to assist us in completing the study as expeditiously as possible. We believe our overall success will be driven by continued execution on clinical and regulatory milestones, and we are pleased to commence patient enrollment in our pivotal U.S. study just days after announcing that APPY1 is now a CE Marked product in Europe. Over the coming months while the study is ongoing, we intend to launch APPY1 in initial EU territories, as well as continue working across our network of more than